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Comparison of effect of adding Drakshavaleha to iron tablets in women with low Hemoglobin levels

Phase 4
Not yet recruiting
Conditions
Health Condition 1: D509- Iron deficiency anemia, unspecified
Registration Number
CTRI/2024/05/067169
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1 Women of reproductive age group (18 to 49 years) with mild (Hb 11-11.9) to moderate (Hb 8 to 10.9 g/dL) anemia

2 Serum ferritin less than 30 mcg/dL

3 Should consent to receive any type of intervention before randomization.

4 Not participating in any other research study

Exclusion Criteria

1 Pregnant and lactating women

2 Known cases of anemia due to other causes (Sickle cell anemia; Thalassemia minor)

3 Those who are already consuming IFA greater than 14 days

4 HbA1C greater than 6.5%

5 Known Diabetics on regular medicines

6 Known allergy to iron and ingredients of Drakshavaleha

7 Patient with known chronic kidney and liver disease

8 Any other condition in the advice of the treating doctor that is putting the participant on risk due to study participation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hb levelTimepoint: Baseline <br/ ><br>1 month <br/ ><br>2 months <br/ ><br>3 months
Secondary Outcome Measures
NameTimeMethod
quality-of-life score using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scaleTimepoint: Baseline <br/ ><br>3 months;Serum iron <br/ ><br>Total Iron binding capacity <br/ ><br>Ferritin <br/ ><br>Transferrin saturation <br/ ><br>RBC <br/ ><br>MCV <br/ ><br>MCH <br/ ><br>MCHCTimepoint: Baseline <br/ ><br>1 month <br/ ><br>2 months <br/ ><br>3 months
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